Bioinformatics: finding legal framework

Yana Briuzghina, 111-i, KNEU

Introduction

With the development of science, the flood of data in biology such as complete genomes of biological species, etc, such things as data capture, data warehousing and data mining have become major issues for biotechnologists and biological scientists.

Bioinformatics – Definition:

So what is the bioinformatics itself?

Bioinformatics can be defined as a branch of science where one can interpret, compare and analyse biological data. It has emerged as a new discipline trying to solve complex problems in life sciences, particularly in biotechnology.

Bioinformatics development trends

Though Hwa Lim, Father of Bioinformatics, coined the word ‘bio-informatique’ in 1987, but Temple Smith used the term ‘Bioinformatics’ in 1991. New computer methods to analyze and compare a large number of protein sequences of different organisms were needed because handling many amino acid sequences manually was impractical.

This led in compiling the first “Protein Information Resources” by Margaret Oakley Dayhoff and her collaborators at the National Biomedical Research Foundation.

Dayhoff’s team successfully organized the protein sequences into distinct groups and sub-groups based on sequence similarity and percent accepted mutation matrices. With the objective of providing the theoretical background to immunology experiments in 1974, George Bell and colleagues initiated the collection of DNA sequences into GenBank .

During 1982–1992, the first version of GenBank was prepared by Walter Goad’s group and the efforts resulted in the development of presently known and widely used DNA sequence databases of GenBank, “The European Molecular Biology Laboratory and DNA DataBank of Japan in 1979, 1980, and 1984, respectively .

 Such first developments and resulting computer software called “GENEINFO” and its derivative version of “Entrez” were developed by David Benson and David Lipman and colleagues. 

Legal issues and solutions in bioinformatics

There is a vast array of bioinformatics software programs, many of which are used in sequence analysis in various ways. Commercial value or the protection is realised in bioinformatics through the exploitation of IPRs in the biological molecules, databases and software.

Both public domain and proprietary or commercial databases benefit from IPR protection. Bioinformatics databases may be considered to occur at many points along a public–commercial continuum with some databases essentially falling part in and part out of the public domain.

Tables 1 and 2 provide an overview summary of the intellectual property position in both the EU and the USA.

Table 1: Summary diagram of IPR protection in bioinformatics in the EU

Table 2: Summary diagram of IPR protection in bioinformatics in the USA

Additional protection

Copyright:

The first is the structure and form of the database given by way of copyright protection. Copyright protection in databases is available to natural or legal persons of third countries and parties to the World Trade Organization TRIPs Agreement (except for a shorter term of protection – 50 years after the death of the author compared with 70 years under Directive 93/98 EEC).

Copyright protection is available in the database irrespective of whether the individual components of the database attract copyright.

Patents:

The position in the EU regarding bioinformatics method patents is considered in detail in the next section on bioinformatics software.

In the USA data structures per se are not patentable but a computer or CD-ROM/ floppy disk encoded with a data structure is patentable.

This is laid down in Guidelines (1996) of the United States Patent and Trademark Office.

Summary

With the current deluge of data, computational methods have become indispensable to biological investigations. Originally developed for the analysis of biological sequences, bioinformatics now encompasses a wide range of subject areas including structural biology, genomics and gene expression studies.

People like Margaret Oakley Dayhoff, David Benson and David Lipman, Hwa Lim and organizations such as Walter Goad’s and The European Molecular Biology Laboratory and DNA DataBank of Japan have helped to develop the bioinformatics and organize the data.

As far as the law issues of bioinformatics is concerned, there is a vast array of bioinformatics software programs, many of which are used in sequence analysis in various ways. Commercial value is realised in bioinformatics through the exploitation of IPRs in the biological molecules, databases and software.

There are 2 types of protection:

-Copyright protection in databases is available to natural or legal persons of third countries and parties to the World Trade Organization TRIPs Agreement.

-Patents. In the USA data structures per se are not patentable but a computer or CD-ROM/ floppy disk encoded with a data structure is patentable.\

Proposals

Based on the conclusions, it seems appropriate to propose the adoption by the Verkhovna Rada of Ukraine of the Law on “Bioinformatics” as Bioinformatics is constantly developing and it’s NEW, this can be a good investment to the Ukrainian government that will pay off in the future if Ukraine takes part in the investigation.

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